1. Field of the Invention
The procedure of choice to correct or relieve blocked or diseased luminal viscera of the body, such as the bowel, bile duct, ureter, and blood vessels in the medical field involves ligation and surgical anastomosis. Typically, a blocked or restricted luminal viscus, or a lesion or tumor on the viscus wall, is repaired whereby the abnormal portion is removed forming a break in the lumen. The break is then repaired by rejoining the two healthy luminal portions. Commonly, this was done by the surgeon with hand stitches or surgical staples. This procedure is performed on numerous tubular organs of the body, including the intestines and bowel, the bile duct, ureter, fallopian tubes, and blood vessels. These previous methods proved time consuming and required a great amount of skill and effort on the part of the surgeon. Additionally, this hand method is quite invasive as it cannot be satisfactorily done through laparoscopic techniques.
To simplify the task of reconnecting the severed lumens, known as anastomosis, there have been various attempts to utilize stents comprised of a biocompatible material inside the lumen to serve as a structure upon which to staple the two luminal stumps together. Such stents are typically of a general hollow cylindrical shape, and made from a rigid biocompatible material which will dissolve and absorb safely into the body after the anastomosis is complete.
2. Prior Art
U.S. Pat. No. 5,653,744 issued to Khouri relates to the use of such stent devices in the anastomosis of blood vessels. The stent is comprised of a material which is biocompatible and can be converted by heat into a liquid which is completely and safely miscible in blood.
U.S. Pat. Nos. 5,141,516 and 5,549,122, both issued to Detweiler, relate to a two-piece intraluminal stent for vessel anastomosis. The pieces are designed to interfit together such that a piece is placed inside the end of each vessel stump such that the stumps can be then locked together by joining the stent pieces. The vessel's stump ends are then permanently joined with a glue-like biocompatible sealant. The stent pieces are comprised of a dissolvable, biocompatible material, such as a crystallized saccharide, such that stent completely dissolves within several hours after anastomosis.
Additionally, attempts have been made in the art to utilize transient biocompatible stents comprised of polyglycolic acid, or “PGA,” in the shape of rigid hollow cylinders. Schmidt, R. A., “Experimental Technique for (Laparoscopic) Bowel Anastomosis: Transient Enduluminally Stented Anastomosis (TESA),” Surgical Laparoscopy & Endoscopy, 7(4):281–284 (1997). The opposing vessel stumps are fit over the PGA stent and permanently joined using sutures or surgical staples. Also known is the BAR, or Biofragmentable Anastomotic Ring, which was used clinically very briefly, due to its awkwardness and difficulty in using.
The above mentioned attempts have been unsuccessful in providing an adequately simplified method for anastomosis. The above methods still require a great deal of effort in their use, and their designs make them quite restrictive when used in tight quarters such as during laparoscopic procedures. It is therefore an object of this invention to provide an improved method and device for mammalian anastomosis.